MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HYSTEROSCOPE SHEATH, 5 MM

Model Number	26153EA
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The customer mentioned noted debris inside the shaft and corrosion.It is beleived that the customer was using the non-recommended cleaning solution.The previous reportability decision for this event was reversed based on a retrospective review the event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that the surgeon observed debris possibly coming from the sheath.It was an appearance of metallic flakes is was small enough that it could not be seen by the naked eye only through the scope and camera.

• Brand Name: HYSTEROSCOPE SHEATH, 5 MM
• Common Device Name: HYSTEROSCOPE SHEATH
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 17873605
• Report Number: 2020550-2023-00275
• Device Sequence Number: 4401614
• Product Code: HET
• UDI-Device Identifier: 04048551094167
• UDI-Public: 4048551094167
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2023
• Report Date (Section F): 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 26153EA
• Device Catalogue Number: 26153EA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/26/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/04/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown